1-3기 위식도암 생존자의 신체 기능 향상을 위한 맞춤형, 감독형, 원격 운동 중재, PRECISE 임상시험 (PRECISE)

Patients receive access to the Moterum application and complete remotely delivered, supervised exercise sessions, over 1 hour, 3 times per week for 8 weeks. Sessions consist of both aerobic and resistance training exercises. Patients also receive written instructions and videos of strengthening exercises. Patients undergo blood sample collection throughout the study.

Undergo blood sample collection

• 생물학적 샘플 수집
• 생체 표본 수집
• 표본 수집

Ancillary studies

Ancillary studies

Ancillary studies

Receive written instructions

• 중재 교육
• 교육에 의한 개입
• 교육을 통한 개입
• 개입, 교육

Receive videos of strengthening exercises

• 중재 교육
• 교육에 의한 개입
• 교육을 통한 개입
• 개입, 교육

Compete exercise sessions

Receive access to Moterum application

Ancillary studies

• 체력 테스트
• 신체 기능 테스트

Will use descriptive statistics to summarize the participant population, feasibility metrics, and safety data. The study will be deemed feasible if > 60% (12 or more) of the 20 enrolled participants are retained.

Assessed via Short Physical Performance Battery. Will perform exploratory statistical comparisons between baseline and end of study endpoints using t-tests and Fisher exact tests to explore the efficacy of the exercise intervention.

Will perform exploratory statistical comparisons between baseline and end of study endpoints using t-tests and Fisher exact tests to explore the efficacy of the exercise intervention.

Assessed via the two minute step test. Will perform exploratory statistical comparisons between baseline and end of study endpoints using t-tests and Fisher exact tests to explore the efficacy of the exercise intervention. The two-minute step test is administered by measuring the midpoint of the participant's patella and the top of their iliac crest and measuring how many times the participant's right knee can reach this point while marching in place for 2 minutes. A higher step count means a better outcome.

Will perform exploratory statistical comparisons between baseline and end of study endpoints using t-tests and Fisher exact tests to explore the efficacy of the exercise intervention. The activities of daily living assessment is a calculated from the physical component score of the Short Form-36 health survey. This section consists of 10 items that assess different physical activity domains. Each item has a specific response scale which corresponds to a number. These numbers are summed and transformed into a 0-100 scale, where 0 indicates the worst health and 100 indicates the best health.

Will perform exploratory statistical comparisons between baseline and end of study endpoints using t-tests and Fisher exact tests to explore the efficacy of the exercise intervention. The instrumental activities of daily living assessment is a 10 items survey that assess different physical activity domains. Each item will be rated and scored based on responses denoting level of limitation (a lot, a little, not at all). The total score ranges from 0 to 100 and higher scores means a better outcome.

Assessed via Deficit Accumulation Index. Will perform exploratory statistical comparisons between baseline and end of study endpoints using t-tests and Fisher exact tests to explore the efficacy of the exercise intervention. The Deficit Accumulation Index (DAI) is a 50-item frailty index that is derived from the Cancer and Aging Research Group geriatric assessment. The DAI evaluates deficits in multiple geriatric assessment domains. Scores range from 0-1 with a score of 0.0 representing no detected deficits and 1.0 representing the maximum deficit. Based on the score, participants will be categorized into three categories of health status: robust, prefrail, or frail.

Assessed via Montreal Cognitive Assessment. Will perform exploratory statistical comparisons between baseline and end of study endpoints using t-tests and Fisher exact tests to explore the efficacy of the exercise intervention. The Montreal Cognitive Assessment (MoCA) test is a series of questions and assessments to measure eight domains of cognitive function. The MoCA is score from 0-30 with lower scores indicating worse cognitive impairment. A score of <25 suggests some degree of cognitive impairment.

Assessed via Patient Reported Outcomes Measurement Information System Cognitive Function Short Form. Will perform exploratory statistical comparisons between baseline and end of study endpoints using t-tests and Fisher exact tests to explore the efficacy of the exercise intervention. The PROMIS Short Form v2.0 - Cognitive Function Short Form 8a provides a self-reported measure of cognitive function consisting of 8 items. Each item includes a statement related to cognitive function that the patient would rate with an attribution (very often (several times a day), often (about once a day), sometimes (two or three times), rarely (once), never) that ranges from 0-5. The items will be summed to obtain a composite score from 0-40 and higher scores indicate better cognitive function.

Assessed via 36-Item Short Form Survey. Will perform exploratory statistical comparisons between baseline and end of study endpoints using t-tests and Fisher exact tests to explore the efficacy of the exercise intervention. The 36-Item Short Form Health Survey (SF-36) is a composite measure of quality of life that includes 36 items related to physical (10 items) and social functioning (2 items), pain (2 items), role limitations due to physical health (4 items) and emotional problems (3 items), energy/fatigue (4 items), emotional well-being (5 items), and health perceptions (6 items). Each item is scored on a 0 to 100 range, in which a high score represents a more favorable health state.

Assessed via Insomnia Severity Index. Will perform exploratory statistical comparisons between baseline and end of study endpoints using t-tests and Fisher exact tests to explore the efficacy of the exercise intervention. The Insomnia Severity Index is a self-rated questionnaire that assesses sleep problems over a 2-week time interval. Higher scores indicate more acute symptoms of insomnia (no clinically significant insomnia [0-7], subthreshold insomnia [8-14], moderate clinical insomnia [15-21], severe clinical insomnia [22-28]).

Assessed via General Anxiety Disorder-7. Will perform exploratory statistical comparisons between baseline and end of study endpoints using t-tests and Fisher exact tests to explore the efficacy of the exercise intervention. The General Anxiety Disorder-7 is a 7-item questionnaire that assesses anxiety severity over a 2-week time interval. This is calculated by assigning scores of 0 (not at all), 1 (several days), 2 (more than half the days), and 3 (nearly every day) to each response. GAD-7 total score for the 7 items ranges from 0 to 21 with higher scores indicating more anxiety (minimal anxiety [0-4], mild anxiety [5-9], moderate anxiety [10-14], severe anxiety [15-21]).

Assessed via Patient Health Questionnaire-8. Will perform exploratory statistical comparisons between baseline and end of study endpoints using t-tests and Fisher exact tests to explore the efficacy of the exercise intervention. The Patient Health Questionnaire-8 is an 8-item questionnaire that assesses depression over a 2-week time interval. This is calculated by assigning scores of 0 (not at all), 1 (several days), 2 (more than half the days), and 3 (nearly every day) to each response. Higher scores indicate a higher likelihood of clinical depression.

Assessed via National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Will be determined at each time point per patient as the presence (yes/no) of toxicities of grade ≥ 2. Will perform exploratory statistical comparisons between baseline and end of study endpoints using t-tests and Fisher exact tests to explore the efficacy of the exercise intervention. Adverse Events (AEs) experienced will be captured as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0). After grading, each AE will be assigned an attribution by the treating clinician (unlikely, possibly, probably, or definitely related to study agent).

Assessed via Patient Reported Outcomes version of CTCAE. Will perform exploratory statistical comparisons between baseline and end of study endpoints using t-tests and Fisher exact tests to explore the efficacy of the exercise intervention. Patient-reported Adverse Events (PRO-CTCAE) is a patient-reported outcome measurement system developed to evaluate symptomatic toxicity in patients on cancer clinical trials. Each item is scored 0-4 with higher scores indicated more severe symptoms. No total score is calculated.

Assessed via Was it Worth It (WIWI) questionnaire. Will use descriptive statistics to summarize the proportion of participants who answer 'yes,' 'uncertain,' and 'no' to the items in the WIWI Questionnaire and compare responses between participants with improvement in physical function and those without, bivariately and multivariately controlling for other factors.